Company
United StatesNuclein LLC, Austin, TX – FDA Inspections
Inspection records and compliance data for Nuclein LLC in Austin, TX. 1 FDA inspection on record, 1 Form 483, last inspected January 13, 2026.
Company Profile
This profile covers Nuclein LLC based in Austin, TX, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected January 13, 2026.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Investigation of device failures1 inspection
- Sampling plans1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 13, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1286088 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Nuclein LLC
FEI Number
3014515702
Address
8305 Cross Park Dr, Austin, TX 78754-5154, United States
Country
United States
ID: 676f17bb-67c9-4e1f-95fe-e0d4acc57e53